Complete FDA and NHTSA recall records dated in October 2020.
These records include useful source details for the selected month.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Lack of sterility assurance of the 30-0171
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing…
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
